US11583384B2 - Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone - Google Patents

Abstract

Devices, systems and/or methods for repairing soft tissue adjacent a soft tissue repair site. In one embodiment, a repair device includes an anchor member, a capture member and one or more flexible members. The anchor member includes a base with at least four legs extending integrally from the base, the at least four legs configured to be moveable from a straight first position to a formed second position. The capture member is configured to be coupled to the anchor member such that the at least four legs of the anchor member move around structural portions of the capture member with the at least four legs of the anchor member in the formed second position. The one or more flexible members are coupled to the base of the anchor member, the one or more flexible members extending at least partially along the base of the anchor member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. Provisional Application No. 62/464,300, filed Feb. 27, 2017, U.S. Provisional Application No. 62/608,533, filed Dec. 20, 2017, and U.S. Provisional Application No. 62/633,000, filed Feb. 20, 2018, the disclosures of each are hereby incorporated by reference in their entirety. The present application also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 15/870,447, filed Jan. 12, 2018, which claims the benefit of U.S. Provisional Application No. 62/581,031, filed Nov. 2, 2017, U.S. Provisional Application No. 62/464,300, filed Feb. 27, 2017, and U.S. Provisional Application No. 62/445,596, filed Jan. 12, 2017, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 15/870,447 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 15/719,346, filed Sep. 28, 2017, which claims the benefit of U.S. Provisional Application No. 62/401,042, filed Sep. 28, 2016, the disclosures of which are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 15/719,346 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/885,959, filed Oct. 16, 2015, now U.S. Pat. No. 10,219,804, which claims the benefit of U.S. Provisional Application No. 62/215,739, filed Sep. 9, 2015, U.S. Provisional Application No. 62/129,742, filed Mar. 6, 2015, U.S. Provisional Application No. 62/094,032, filed Dec. 18, 2014, and U.S. Provisional Application No. 62/064,533, filed Oct. 16, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 14/885,959 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/645,924, filed Mar. 12, 2015, now U.S. Pat. No. 9,629,632, which claims the benefit of U.S. Provisional Patent Application No. 62/053,056, filed Sep. 19, 2014, U.S. Provisional Patent Application No. 62/040,451, filed Aug. 22, 2014, U.S. Provisional Patent Application No. 62/007,783, filed Jun. 4, 2014, and U.S. Provisional Patent Application No. 61/952,114, filed Mar. 12, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, the present application also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/885,956, filed Oct. 16, 2015, now U.S. Pat. No. 10,390,935, which claims the benefit of U.S. Provisional Patent Application No. 62/064,533, filed Oct. 16, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety.

TECHNICAL FIELD

The present invention relates generally to soft tissue repair sites. More particularly, the present invention relates to devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone.

BACKGROUND

One of the most common needs in orthopedic surgery is the fixation of soft tissue, such as ligament or tendon, to bone. Typically, fixating soft tissue to bone is implemented with a bone anchor and suture material with suture coupled between the soft tissue and the bone anchor such that the soft tissue is cinched in against the bone. However, coupling suture to soft tissue is time consuming and often requires complex suture patterns for effective fixation, often requiring specialized surgeons. While this can provide a good initial repair, the strength and quality of the repair may quickly degrade with subsequent loading and mobilization, depending on the activity level of the patient, which often results. As such, it would be advantageous to eliminate the complexity and the time consuming nature of this type of surgery while also increasing the long term effectiveness of the procedure.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices, systems and methods for repairing soft tissue at a soft tissue repair site. For example, in one embodiment, a repair device for fixating to soft tissue at a soft tissue repair site is provided. The repair device includes an anchor member, a capture member, and one or more flexible members. The anchor member includes a base with at least four legs extending integrally from the base, the at least four legs configured to be moveable from a straight first position to a formed second position. The capture member is configured to be coupled to the anchor member such that the at least four legs of the anchor member move around structural portions of the capture member with the at least four legs of the anchor member in the formed second position. The one or more flexible members are coupled to the base of the anchor member, the one or more flexible members extending at least partially along the base of the anchor member.

In another embodiment, the base includes multiple recesses defined therein, the recesses sized and configured to receive the one or more flexible members for coupling the one or more flexible members to the base. In another embodiment, the at least four legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the at least four legs, the first and second tapers of the at least four legs sized and configured to facilitate the at least four legs to be moveable to the formed second position. In still another embodiment, the at least four legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member.

In another embodiment, the one or more flexible members includes one or more filaments sized and configured to wrap around portions of the base. In still another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In yet another embodiment, the one or more flexible members are configured to be coupled to a bone anchor.

In another embodiment, the capture member extends with multiple apertures defined therein, each one of the multiple apertures sized and configured to correspond with one of the at least four legs of the anchor member. In still another embodiment, the capture member extends with a generally flat configuration.

In accordance with another embodiment of the present invention, a repair device system for fixating soft tissue to bone is provided. The repair device system includes a bone anchor with an elongated structure, a soft tissue anchor member, and one or more flexible members. The soft tissue anchor member includes a base with multiple legs integrally extending from the base, the legs configured to be moveable from a straight first position to a formed second position, the soft tissue anchor configured to be coupled to soft tissue with the legs in the formed second position. With this arrangement, the soft tissue anchor is coupled to the bone anchor with the one or more flexible members.

In another embodiment, the repair device system further includes a capture member configured to be coupled to the anchor member such that the legs of anchor member curl around structural portions of the capture member with the legs in the formed second position. In another embodiment, the capture member extends with a generally flat configuration. In still another embodiment, the capture member includes tines configured to extend upward toward the base of the anchor member.

In another embodiment, the multiple legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member. In another embodiment, the multiple legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the legs, the first and second tapers of the legs sized and configured to facilitate the legs to be moveable to the formed second position. In another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the first flexible member coupled to the base of the soft tissue anchor member and the second flexible member directly coupled to the first flexible member and coupled to the bone anchor.

In accordance with another embodiment of the present invention, a method for fixating to soft tissue at a soft tissue repair site is provided. The method including the steps of: providing a delivery device coupled to an anvil with an anvil surface having anvil buckets defined therein, the delivery device configured to hold an anchor member with a base and at least four legs integrally extending from the base, the anchor member including one or more flexible members coupled to the base; positioning soft tissue over the anvil surface of the anvil; and forcing the at least four legs of the anchor member with the delivery device through the soft tissue to then compress the at least four legs into the anvil buckets so that the at least four legs of the anchor member are formed to couple to the soft tissue.

In another embodiment, the method step of providing includes providing a capture member over the anvil surface so that, upon forcing the at least four legs, the at least four legs wrap around structural portions of the capture member so that the soft tissue is captured between the base of the anchor member and the capture member. In another embodiment, the method further includes the step of coupling the one or more flexible members to a bone anchor. In still another embodiment, the method step of forcing includes forcing the one or more flexible members through the soft tissue with a needle structure.

In accordance with another embodiment of the present invention, a repair device system for fixating soft tissue to bone with a bone anchor is provided. The repair device system including a delivery device and an anchor member. The delivery device includes an anvil surface, the anvil surface defining anvil buckets therein. The anchor member includes a base with at least four legs extending from the base. Further, the base includes one or more flexible members coupled thereto. With this arrangement, the at least four legs are configured to be compressed against the anvil buckets to move the at least four legs to a formed configuration for fixation to the soft tissue and the one or more flexible members are configured to be coupled to the bone anchor.

In another embodiment, the repair device system further includes a capture member, the capture member configured to be positioned over the anvil surface and configured to be captured by the at least four legs of the anchor member upon the at least four legs being moved to the formed configuration. In another embodiment, the one or more flexible members are configured to be coupled to a bone anchor. In still another embodiment, the one or more flexible members includes a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In another embodiment, the delivery device includes a needle structure sized and configured to deliver the one or more flexible members through the soft tissue.

In accordance with another embodiment of the present invention, a repair device for fixating to soft tissue at a soft tissue repair site is provided. The repair device includes an anchor member and one or more flexible members. The anchor member includes a base with at least four legs integrally extending from the base, the at least four legs sized and configured to move from a straight first position to a formed second position. The one or more flexible members are coupled to the base of the anchor member, the one or more flexible members extending adjacent a periphery of the base.

In another embodiment, the one or more flexible members are coupled to the anchor member by wrapping the one or more flexible members around portions of the base. In another embodiment, the one or more flexible members are configured to be coupled to a bone anchor. In still another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In still another embodiment, the base includes recesses defined therein, the recesses sized and configured to facilitate coupling the flexible member to the base. In yet another embodiment, the formed second position of the at least four legs of the anchor member exhibit a curled configuration.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:

FIG.1 is a perspective view of an anchor member of a repair device, depicting the anchor member having one or more flexible members attached thereto, according to an embodiment of the present invention;

FIG.2 is a perspective view of a capture member of the repair device for coupling to the anchor member ofFIG.1, according to another embodiment of the present invention;

FIG.3 is a perspective view of the repair device in a pre-deployed state, depicting legs of the anchor member aligned relative to coupling structure of the capture member, according to another embodiment of the present invention;

FIG.4 is a perspective view of the repair device ofFIG.3 in a deployed and coupled state, depicting legs of the anchor member formed around coupling structure of the capture member, according to another embodiment of the present invention;

FIG.5 is a perspective view of the repair device associated with an anvil, depicting the anchor member in the pre-deployed state as positioned within a cartridge (not shown) and positioned above the capture member disposed on the anvil, according to another embodiment of the present invention;

FIG.6 is a top view of the anvil ofFIG.5, according to another embodiment of the present invention;

FIG.7 is an exploded view of an implant delivery member and the repair device, according to another embodiment of the present invention;

FIG.8 is a perspective of a delivery device disengaged with the implant delivery member, according to another embodiment of the present invention;

FIG.8A is an enlarged perspective view of the implant delivery member, according to the present invention;

FIG.9A is a cross-sectional view of the delivery device taken alongsection line9A-9A ofFIG.8, according to another embodiment of the present invention;

FIG.9B is a cross-sectional view of the delivery device, depicting the implant delivery member engaged with the delivery device, according to another embodiment of the present invention;

FIG.10 is a cross-sectional view of the implant delivery member taken along section line A-A ofFIG.8A, according to another embodiment of the present invention;

FIG.11 is a simplified side view of the repair device ofFIG.4 coupled to soft tissue, depicting a flexible member extending from the repair device and the soft tissue, according to another embodiment of the present invention;

FIG.11A is a simplified side view of another embodiment of a repair device coupled to soft tissue, depicting a flexible member extending from an anchor member and the soft tissue, according to the present invention;

FIG.12 is a simplified side view of the repair device coupled to soft tissue, depicting a bone anchor and a suture extending from the repair device, according to another embodiment of the present invention;

FIG.13 is a simplified side view of the repair device coupled to soft tissue, depicting a bone anchor seated within bone with a flexible member extending from the bone anchor, according to the present invention;

FIG.14 is a simplified side view of the repair device coupled to soft tissue, depicting a bone anchor coupled to the repair device with a flexible member, according to another embodiment of the present invention;

FIG.15 is a simplified side view of another embodiment of the repair device coupled to soft tissue, depicting a post configured to cooperate with the repair device, a flexible member and a bone anchor, according to another embodiment of the present invention;

FIG.16 is a simplified side view of another embodiment of the repair device coupled to soft tissue, depicting a post configured to cooperate with the repair device and a flexible member extending from a bone anchor seated within bone, according to another embodiment of the present invention;

FIG.17A is a perspective view of another embodiment of an anchor member of a repair device, according to the present invention;

FIG.17B is a perspective view of another embodiment of a capture member, according to the present invention;

FIG.18A is a perspective view of another embodiment of an anchor member of a repair device, according to the present invention;

FIG.18B is a perspective view of another embodiment of a capture member, according to the present invention;

FIG.19A is a perspective view of another embodiment of anchor member of a repair device, according to the present invention;

FIG.19B is a perspective view of another embodiment of a capture member, according to the present invention;

FIG.20 is a perspective view of another embodiment of an anchor member of a repair device, according to the present invention;

FIG.21 is a perspective view of another embodiment of an anchor member of a repair device, according to the present invention;

FIG.22 is a top view of another embodiment of an anchor member of a repair device, depicting one or more flexible members coupled to the anchor member, according to the present invention;

FIG.23 is a top view of another embodiment of an anchor member of a repair device, depicting one or more flexible members coupled to the anchor member, according to the present invention;

FIG.24 is a top view of another embodiment of an anchor member of a repair device, depicting one or more flexible members coupled to the anchor member, according to the present invention;

FIG.25 is a perspective view of another embodiment of a repair device, depicting the repair device having a bone anchor portion with legs in an unformed first state, according to the present invention;

FIG.26 is a perspective view of the repair device ofFIG.25, depicting the legs extending from the bone anchor portion in a formed second state, according to another embodiment of the present invention; and

FIG.27 is a simplified side view of the repair device ofFIG.26, depicting the bone anchor portion seated in bone with the legs coupled to soft tissue, according to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments are disclosed herein of a soft tissue repair device and system. Such repair device and system may be sized and configured to approximate and fuse, for example, soft tissue to bone. The various embodiments may provide structure that maintains the soft tissue against bone in an abutting relationship, without gapping. In this manner, the repair device and system of the present invention may provide the proper healing required for fusing the soft tissue to bone.

Now with reference toFIGS.1 and2, one embodiment of arepair device10 that may include ananchor member12 and acapture member14 is provided. Theanchor member12 may be sized and configured to cooperate with thecapture member14 for coupling to soft tissue, such as tendon or ligament type soft tissue.Such repair device10 may include one or moreflexible members16 that may be coupled thereto for coupling to, for example, a bone anchor152 (FIG.12) with the soft tissue held against the bone and over or adjacent thebone anchor152. Further, therepair device10 may be deployed from a delivery device11 (FIG.8) so that the repair device may be fixated to soft tissue.

With respect toFIG.1, theanchor member12 of this embodiment may include one or moreflexible members16, such as a firstflexible member17, that may be coupled to theanchor member12. Further, theanchor member12 may include a base18 withlegs20 extending downward from thebase18. The base18 may include a circular structure or profile, such as a ring like structure, or any other suitable structure sized and configured to couple the one or moreflexible members16 thereto and having thelegs20 extending therefrom. The base18 may include anouter periphery22 and aninner periphery24 such that thelegs20 may extend from theouter periphery22. In another embodiment, thelegs20 may extend from theinner periphery24. Further, thebase18 may define anupper surface26 and alower surface28 extending to theouter periphery22 and theinner periphery24 of thebase18. The base18 may define atissue anchor axis27 extending centrally and axially relative to thebase18 and extending substantially parallel relative to thelegs20. Further, in another embodiment, thelegs20 may extend from theouter periphery22 with a curvature orcurved portion21 to then continue extending away from the base18 in a substantially linear or straight manner so that thelegs20 may extend substantially perpendicular relative to thelower surface28 or underside of thebase18.

In one embodiment, thebase18 may includecoupling structure29 for coupling the one or moreflexible members16 to thebase18.Such coupling structure29 may include recesses, notches, protrusions, and/or openings formed in thebase18. Thecoupling structure29 of theanchor member12 may also include a portion of thelegs20, such as thecurved portion21 of thelegs20 or leg portions adjacent thebase18. In this manner, thelegs20 may be employed, at least in part, as thecoupling structure29. For example, thecoupling structure29 formed in thebase18 may includemultiple recesses30 defined in the base, therecesses30 sized and configured to facilitate wrapping the firstflexible member17 to thebase18 of theanchor member12.Such recesses30 may be defined in theouter periphery22 of thebase18 and may extend between theupper surface26 and thelower surface28 of thebase18. Theinner periphery24 of the base18 may extend withbumps32 or protrusions that correspond with therecesses30 defined in thebase18.

The one or moreflexible members16 may be formed from one or more filaments or fibers. The filaments or fibers may be formed from a polymeric material or a natural fiber. In one embodiment, the filaments or fibers may be a polyethylene material, such as ultra-high-molecular-weight polyethylene (“UHMWPE”), a polyester material, a polypropylene material, or the like. In another embodiment, the one or moreflexible members16 may be formed of suture material and/or extend as a suture. In another embodiment, the polymeric filament or fiber may be a bioresorbable material, such as polylactide (“PLA”), polycaprolactone (“PCL”), polydioxanone (“PDX”), or the like, or any other suitable bioresorbable material as known to one of ordinary skill in the art. In another embodiment, the filaments or fibers may be formed in a woven or braided configuration or may extend with strands wound in a side-by-side configuration, or may extend with strands wound side-by-side and in a twisted configuration or any other suitable configuration to form a flexible member. In another embodiment, the one or moreflexible members16 may be a continuous loop. In another embodiment, the continuous loop may include a woven or braided structure. In another embodiment, the one or moreflexible members16 may extend with at least two free ends.

Theanchor member12 may be laser cut from sheet material or cut from the sheet material with any other suitable process. As such, theanchor member12 may be a monolithic structure or a seamless unitary structure. The base18 may include an outer diameter and an inner diameter, the outer diameter defined by theouter periphery22 and the inner diameter defined by theinner periphery24. Theinner periphery24 of the base18 may define acentral opening25 of thebase18. In one embodiment, thetissue anchor axis27 may be centrally located so that thetissue anchor axis27 extends axially through thecentral opening25. The base18 may also define athickness34 similar to the thickness of the sheet material. As such, thebase18 may extend with a substantially flat structure or configuration with theupper surface26 and thelower surface28 being substantially planar. Theouter periphery22 andinner periphery24 of the base18 may extend radially relative to the tissue anchor axis27 (or about the axis27) along a majority of the outer andinner peripheries22,24 such that the outer and inner peripheries exhibit a generally circular profile (as viewed from the top or bottom of the anchor member12). Further, thelegs20 may include alength36, awidth38, and adepth40, the depth being similar to the thickness of thebase18, which also may correspond with the thickness of the sheet material. Thewidth38 may include multiple tapers along thelongitudinal length36 of thelegs20. For example, thewidth38 may include afirst taper42 and asecond taper44, each of which may be sized and configured to manipulate a direction and orientation for thelegs20 to curl and/or wrap upon being compressed against an anvil (not shown), discussed further herein. Thefirst taper42 may extend from adjacent to thecurved portion21 of the legs along a majority of thelength36 of thelegs20. Thesecond taper44 may extend from an end of the first taper to afree end43 of thelegs20 such that thesecond taper44 is shorter than thefirst taper42.

With reference toFIGS.1 and2, thecapture member14 will now be described. Thecapture member14 may be sized and configured to be captured by thelegs20 of theanchor member12 with tissue therebetween (seeFIG.1). Thecapture member14 may include a pentagon type profile, or any other suitable profile, such as a circular profile or the like that may be employed for cooperating with and capturing thelegs20 of theanchor member12. Thecapture member14 may include coupling structure that may defineapertures46, recesses, notches or protrusions therein. Such coupling structure of thecapture member14, such as theapertures46, recesses, notches, protrusions or any other suitable structure, may be sized and configured to receive and couple to thelegs20 of theanchor member12. In this manner, theapertures46 may be sized and positioned in thecapture member14 to correspond with thelegs20 of theanchor member12.

Further, thecapture member14 may include anupper surface48 and alower surface50 such that theapertures46 extend through and between the upper andlower surfaces48,50 of thecapture member14. Thecapture member14 may also define anouter periphery52 and aninner periphery54 such that theinner periphery54 may define a central opening of thecapture member14. Theupper surface48 and thelower surface50 of the capture member may extend to the outer andinner peripheries52,54 of thecapture member14. Thecapture member14 may also includetines56 extending upward above theupper surface48. Thetines56 may extend from theinner periphery54 and may be sized and configured to engage with soft tissue. Further, thetines56 may extend in an inward canted manner or may extend substantially perpendicular relative to theupper surface48 of thecapture member14.Such capture member14, similar to theanchor member12, may be formed as a monolithic, seamless structure from sheet material. As such, but for thetines56, the capture member may be a substantially flat structure or configuration. Further, theupper surface48 andlower surface50 may extend in a planar manner. Further, the structure of thecapture member14 may define acapture member axis57 that may extend centrally and axially relative to the structure of thecapture member14 such that thecapture member axis57 may extend substantially perpendicular relative to the upper andlower surfaces48,50 of thecapture member14.

In one embodiment, the sheet material for forming theanchor member12 and thecapture member14 may be formed from a metallic material, such as stainless steel, titanium, or Nitinol, or any other suitable medical grade material or combinations of materials. As previously set forth,such anchor member12 andcapture member14 may be laser cut from the sheet material or cut using any suitable technique known in the art. In another embodiment, theanchor member12 may be formed from a polymeric material or a bioresorbable material, formed and manufactured as known by one of ordinary skill in the art. Upon being cut from the sheet material, thelegs20 of theanchor member12 may be bent to position the legs downward or moved to orient the legs to extend away from a single side or underside of theanchor member12. Similarly, thetines56 of thecapture member14 may be bent upward, such as at a canted orientation or substantially perpendicular relative to theupper surface48 of thecapture member14. Once thelegs20 ortines56 have been appropriately oriented and bent into position, theanchor member12 andcapture member14 may undergo an electro polishing or chemical polishing process, as known to one of ordinary skill in the art. In another embodiment, theanchor member12 and/or thecapture member14 may be formed from a medical grade polymeric material, as known to one of ordinary skill in the art. In another embodiment, theanchor member12 and/or the capture member may be formed from a bioresorbable material, as known to one of ordinary skill in the art.

Now with reference toFIGS.3 and4, theanchor member12 may be sized and configured to be coupled to thecapture member14, as depicted. For example, prior to theanchor member12 and thecapture member14 being coupled together, thelegs20 of theanchor member12 may be aligned with theapertures46 of thecapture member14, as depicted inFIG.3, such that thetissue anchor axis27 and thecapture member axis57 may be substantially coaxial or substantially parallel relative to each other. Thelegs20 of theanchor member12 may be aligned to pass through theapertures46 and moved to a formed position so that thelegs20 may curl and wrap around structural portions of thecapture member14. The first andsecond tapers42,44 defined in the width38 (FIG.1) of thelegs20 may be sized and configured to manipulate and provide consistency in thelegs20 being moved from a substantially straight, non-formed first position (FIG.3) to a formed second position (FIG.4). The formed second position of thelegs20 may exhibit a curled configuration along an end portion of thelegs20. In this manner, thecapture member14 may be captured by thelegs20 of theanchor member12 with soft tissue (not shown) therebetween, discussed in more detail herein. In another embodiment, thecapture member14 may include structure, such as notches, protrusions or recesses defined therein, sized and configured to cooperate with thelegs20 so that thelegs20 of theanchor member12 may curl or wrap around structural portions of thecapture member14, in a similar manner depicted inFIG.4. Further, as depicted inFIG.4, upon coupling theanchor member12 to thecapture member14, thetissue anchor axis27 and thecapture member axis57 may extend substantially coaxial or substantially parallel relative to each other.

In one embodiment, as depicted inFIG.3, the one or moreflexible members16 may include the firstflexible member17 and a secondflexible member60. Although not shown inFIGS.1 and4, the secondflexible member60 may be pre-coupled to the firstflexible member17, as shown simplistically inFIG.3 and described in further detail herein. For example, as previously set forth, the firstflexible member17 may be coupled to thebase18 of theanchor member12. Such firstflexible member17 may be employed as a coupling for the secondflexible member60. The secondflexible member60 may extend over one or more portions of the firstflexible member17. For example, the firstflexible member17 may be coupled to thebase18 and extend adjacent thebase18 and along theinner periphery24 of the base18 so as to exhibitmultiple lengths62 or expanses of the firstflexible member17 extending between attachment points at therecesses30 defined in thebase18. The secondflexible member60 may be coupled to the firstflexible member17 along, for example, thelengths62 or a portion of the firstflexible member17. Such coupling of the secondflexible member60 to the firstflexible member17 is depicted inFIG.3 in a simplified manner as extending over the firstflexible member17, but such coupling may be wrapped over or around portions of the firstflexible member17 along eachlength62 or expanse between attachment points so as to be tied or wrapped in a fixed manner to the firstflexible member17. As can be appreciated, such coupling of the secondflexible member60 to the firstflexible member17 may be employed with a variety of configurations. Additional examples of the one or moreflexible members16 and the coupling thereof may be found in commonly owned U.S. Provisional Application No. 62/633,000, the disclosure of which is hereby incorporated herein by reference in its entirety.

In one embodiment, the secondflexible member60 may extend with two free ends. In another embodiment, the secondflexible member60 may extend as a continuous loop. Such free ends or an end portion of a continuous loop may be configured to be coupled to a bone anchor (not shown), discussed further herein. In this manner, alongsuch lengths62 or portions of the firstflexible member17 being the coupling structure, the secondflexible member60 may be wrapped and coupled to the firstflexible member17. With this arrangement, the coupling between the secondflexible member60 and the firstflexible member17 may be more resistant to fatigue, fraying and/or deterioration since the coupling is between flexible members, without rigid edges between the coupling thereof. Further, such coupling may be advantageous because the firstflexible member17 may act somewhat resiliently to any force placed on the secondflexible member60. Further, upon a force being placed upon the secondflexible member60, such as from being coupled to a bone anchor, the coupling of the secondflexible member60 to the firstflexible member17, such as at eachlength62 or expanse, may distribute the force along thebase18 of theanchor member12. In this manner, the one or moreflexible members16 may act to distribute the force along the tissue adjacent therepair device10 as well as minimize the stress being placed upon the soft tissue and the one or moreflexible members16 to, thereby, maintain therepair device10 intact with the soft tissue.

Now with reference toFIGS.5 and6, a portion of animplant delivery member65 configured to couple theanchor member12 to thecapture member14 is provided. Theimplant delivery member65 may include, in part, ananvil70 coupled to aguide portion72 such that theimplant delivery member65 may be configured to couple to a delivery device (not shown). Theguide portion72 may include rails or the like for a cartridge (not shown) to be slidingly coupled thereto, discussed in further detail herein. Theanvil70 may include an anvilupper surface74 withanvil buckets76 defined therein. Theanvil buckets76 may be sized and configured to receive and engage thelegs20 of theanchor member12 to facilitate curling the legs20 (seeFIG.4) into the soft tissue (not shown) positioned over the anvilupper surface74. Further, if employing thecapture member14, thecapture member14 may be positioned and temporarily secured over the anvilupper surface74. For example, the anvilupper surface74 may includemultiple protrusions78 positioned thereon to assist in precisely positioning thecapture member14 over the anvilupper surface74 such that theprotrusions78 may be positioned to correspond with corners of theinner periphery54 of thecapture member14. In this manner, thecapture member14 may be positioned so that theapertures46 defined in thecapture member14 may be positioned over theanvil buckets76 defined in the anvilupper surface74. With thecapture member14 positioned on theanvil70, theanchor member12 may be positioned and aligned above thecapture member12 so that thelegs20 may be aligned with theapertures46 of thecapture member14.Such anchor member12 may be aligned and positioned above thecapture member14 by being held within a cartridge (not shown), discussed in further detail herein.

Once thecapture member14 may be positioned over the anvilupper surface74, the soft tissue may then be positioned over thecapture member14. Theanvil70 may also include aneck portion80 extending laterally from the anvilupper surface74 with anupward extension82 spaced from the anvilupper surface74. Theupward extension82 of theneck portion80 may be coupled to theguide portion72. With thisneck portion80, there is additional space for positioning the soft tissue over the anvilupper surface74 of theanvil70. Upon positioning thesoft tissue5 over the anvil70 (seeFIG.10), theanchor member12 may then be delivered so as to compress thelegs20 through the soft tissue, throughapertures46 of thecapture member14, and into theanvil buckets76. Theanvil buckets76 may be positioned and oriented in the anvilupper surface74 such that thelegs20 of theanchor member12 curl and wrap around structural portions of thecapture member14. In this manner, theanchor member12 may be coupled to thecapture member14 with the soft tissue therebetween, as depicted inFIG.4. Furthermore, the anvilupper surface74 may define anaperture84 extending through theanvil70.Such aperture84 may be employed for the one or moreflexible members16 or second flexible member60 (seeFIG.3) to extend therethrough so that the one or moreflexible members16 may be coupled to a bone anchor152 (FIG.12).

With reference toFIGS.7 and8A, theimplant delivery member65 will now be further described. As previously set forth, theimplant delivery member65 may be sized and configured to temporarily hold and house therepair device10. Suchimplant delivery member65 may be removably engaged with a delivery device11 (FIG.8), for example. Theimplant delivery member65 may include various components that interact and cooperate with thedelivery device11 so that therepair device10 may be deployed and fixated to soft tissue with theanvil70 at an end portion of theimplant delivery member65 and thedelivery device11.

Theimplant delivery member65 may include acradle90, acartridge92 and apusher member94, each of which may be sized and configured to cooperate with therepair device10. Thecartridge92 may be linearly slidable along and coupled to theguide portion72 with a c-arm or channel or the like extending along an underside of thecartridge92. Theguide portion72 may be fixedly coupled to anelongated extension82 of thecradle90. Thecartridge92 may be hollow or define a hollow portion so as to define anopening96 that may extend through opposite sides of thecartridge92. Thepusher member94 may be positionable within a proximal side of the hollow portion or opening96 of thecartridge92. The proximal side of theopening96 may be covered by acap98. Adjacent a distal side of theopening96 or hollow portion, theanchor member12 may be positioned distally adjacent thepusher member94 within thecartridge92. Further, thecartridge92 may defineinternal grooves104 in structure along the distal side of the hollow portion oropening96, theinternal grooves104 sized and configured to hold thelegs20 of theanchor member12 such thatlegs20 of theanchor member12 may be pushed through thecartridge92 and along theinternal grooves104.

In one embodiment, theelongated extension82 extending from theneck portion80 of thecradle90 may be fixedly coupled to atongue portion100.Such tongue portion100 may be coupled to an underside of theelongated extension82, thetongue portion100 andelongated extension82 may act and be referenced as a base or base portion of theimplant delivery member65. Further, thetongue portion100 may includethreads102 along a portion thereof, such as along an upper side of thetongue portion100, thethreads102 sized and configured to engage threads within the delivery device11 (FIG.8). In this manner, theimplant delivery member65 may be readily removed from and coupled to thedelivery device11.

Now with reference toFIGS.8,9A and9B, thedelivery device11 sized and configured to deploy the repair device10 (as depicted inFIG.4) with theimplant delivery member65 will now be described. Thedelivery device11 may include atrigger gun110 with atrigger112. Thetrigger gun110 may be manually actuatable in a physician's hand by manually gripping or actuating thetrigger112, as shown witharrow114. Thedelivery device11 may also include abarrel housing116 defining an axis118. Such axis118 of thedelivery device11 may extend coaxial relative to, or parallel with, thetissue anchor axis27 of theanchor member12 positioned in thecartridge92 and thecapture member axis57 of thecapture member14 positioned over theanvil70. Thebarrel housing116 may house aworm drive120 and apush rod122 co-axial with theworm drive120 and extending longitudinally through theworm drive120.Such push rod122 may be elongated so as to be co-axial or parallel with the axis118. Further,such push rod122 may be configured to cooperate with thetrigger112 so as to distally actuate upon actuating thetrigger112. A detailed description of a suitable trigger handle, capable of providing the force necessary to actuate thepush rod122, is disclosed in U.S. Pat. No. 5,344,061, the disclosure of which is hereby incorporated herein by reference in its entirety. Thebarrel housing116 may also include one ormore openings124 or opposing openings defined therein such that athumb wheel126 may be positioned and accessible for manually rotating therein. Further, thedelivery device11 includes the replaceable and removableimplant delivery member65 such that theimplant delivery member65 may be removable relative to thebarrel housing116.

Thethumb wheel126 of thedelivery device11 may be manually rotatable to cooperate with theworm drive120. As such, the physician may position thetongue100 within anend opening128 or within a bore of thebarrel housing116 and, for example, position thetongue100 within a space below thepush rod122. Once positioned, the physician may rotate thethumb wheel126 so that theworm drive120 may engage thethreads102 of thetongue100 and linearly move and pull thetongue100 within thebarrel housing116. Upon engaging thetongue100, the physician may continue to rotate thethumb wheel126 so that thetongue100 continues proximally so that thepush rod122 moves and slides thecartridge92 distally until thecartridge92 abuts and stops against theanvil70 of thecradle90. Thepush rod122 may include arecess130 at a distal end portion of thepush rod122. Upon thecartridge92 being moved to a distal stop against theanvil70 or cradle, further movement of thethumb wheel126 may move thepush rod122 over alip132 adjacent a proximal side of thecartridge92 so that therecess130 in thepush rod122 engages and may be captured by thelip132. The physician may hear, for example, a click as an assurance that thecartridge92 is engaged with thepush rod122.

At this juncture, thepush rod122 may be engaged with thecartridge92 such that reverse movement of thethumb wheel126 may move thepush rod122 and thecartridge92 proximally with linear movement. The physician may then move thecartridge92 proximally a desired distance to then positionsoft tissue5 over theanvil surface74 and neck portion80 (seeFIG.10). Thecartridge92 may then be moved linearly and distally to an appropriate position adjacent the soft tissue with thethumb wheel126. Once the soft tissue andcartridge92 are appropriately positioned, thetrigger112 of thedelivery device11 may be actuated to move thepush rod122 distally, extending along the axis118, to push against thepusher member94 to then push therepair device10 from thecartridge92 and into the soft tissue. As previously set forth, as thelegs20 of theanchor member12 compress against theanvil buckets76, thelegs20 move to a formed or curled position to wrap around portions of the capture members18 (seeFIGS.4 and5). At this juncture, the physician may then rotate thethumb wheel126 to move thetongue100 andcradle90 distally so that thecartridge92 is backed-off from theanvil70 and so that the user may then readily remove the soft tissue with the deployedrepair device10 therein and from thecradle70.

If it is desired to implant a second repair device in the soft tissue, the user may then continue to rotate thethumb wheel126 to continue to move theimplant delivery member65 distally until theworm drive120 is disengaged from thethreads102 of thetongue100 of theimplant delivery member65. At this stage, the physician may take a second one of theimplant delivery member65 and position it within thebarrel housing116 for engaging with thedelivery device11 as described above to then position a second repair device in the soft tissue, if desired. In this manner, theimplant delivery member65 is removable and replaceable relative to thedelivery device11 so that thedelivery device11 may be repeatably employed with multipleimplant delivery members65.

The components of thedelivery device11 andimplant delivery member65 may be formed and made with medical grade materials, such as stainless steel, titanium, Nitinol, and/or alloys thereof or any other suitable metallic material or polymeric materials, such as liquid crystal polymers or acrylonitrile butadiene styrene (“ABS”) or any other suitable polymeric materials known to one of ordinary skill in the art. Such components of thedelivery device11 may be formed by employing molding and/or machining techniques, or any other suitable techniques and processes known to one of ordinary skill in the art.

With reference toFIG.10, in one embodiment, thecartridge92 of theimplant delivery member65 may include structure for manipulating a position of the one or more flexible members, such as the secondflexible member60, relative to theanchor member12 of the repair device10 (see alsoFIG.3). For example, as previously set forth, thecartridge92 may include thepusher member94 positionable along a proximal side of theopening96 or hollow portion defined in thecartridge92. Further, thepusher member94 may include ahollow needle134 extending from a distal side of thepusher member94. Thehollow needle134 may correspond with ahole136 defined in thepusher member94 that may extend with a curve through thepusher member94. Thehollow needle134 may be sized and configured to correspond with theaperture84 defined in theanvil70. Further, thehollow needle134 fixedly coupled to thepusher member94 may be sized and configured to extend through thecentral opening25 of theanchor member12 positioned within a proximal side of theopening96 of thecartridge92. With thishollow needle134 extending distally from thepusher member94, the secondflexible member60 may extend from the firstflexible member17 at acoupling140 between the first and secondflexible members17,60 (seeFIG.3) such that the secondflexible member60 may extend distally to extend around an end of thehollow needle134. The secondflexible member60 may then extend proximally through aconduit142 of thehollow needle134 and through thehole136 defined in thepusher member94 to continue proximally, for example, through an opening (not shown) in thecap98 to be clipped or the like to an external surface of theimplant delivery member65. With this arrangement, theanchor member12 may be deployed with the push rod122 (FIG.9B) extending through anaperture144 defined in thecap98 to engage aproximal surface146 of thepusher member94. Thepusher member94 may then move theanchor member12 from thecartridge92 to compress thelegs20 against theanvil buckets76 to move thelegs20 around portions of the capture member14 (SeeFIG.5). Further, as thelegs20 are compressed by the pushing force of thepusher member94, thehollow needle134 is also pushed through thesoft tissue5 and through a central opening defined by theinner periphery54 of the capture member14 (FIG.2) and through theaperture84 defined in theanvil70. Upon thehollow needle134 extending through theaperture84 of theanvil70, the secondflexible member60 is pulled distally with thehollow needle134 with portions of the secondflexible member60 extending through thesoft tissue5. The physician may then fully pull the secondflexible member60 completely through thesoft tissue5 and theaperture84 defined in theanvil70. In this manner, the delivery device orimplant delivery member65 may be sized and configured with a needle like structure to deliver the one or more flexible members, such as the secondflexible member60, to the underside of thesoft tissue5. As previously set forth, thecartridge92 may be backed-off from thesoft tissue5 by rotating thethumb wheel126 so that thesoft tissue5 may be removed from the anvil70 (see alsoFIG.9B) with the secondflexible member60 extending from an underside of thesoft tissue5, as depicted inFIG.11.

With reference toFIGS.4 and11, theanchor member12 andcapture member14 of therepair device10 may be coupled together withsoft tissue5 therebetween such that thelegs20 may extend through thesoft tissue5 to be moved to a curled, formed position, as previously set forth, to wrap around portions of thecapture member14. Further, the one or more flexible members may include the secondflexible member60 extending from, and coupled to, the firstflexible member17 such that the secondflexible member60 extends from theanchor member12, through thesoft tissue5, and from an underside of thesoft tissue5. In this manner, therepair device10 may be securely fixated to thesoft tissue5 with the secondflexible member60 extending therefrom. Such secondflexible member60 may be fixedly coupled, for example, to bone with a bone anchor (not shown) or any other structure desired by a physician.

Now with reference toFIGS.1 and11A, in another embodiment, theanchor member12 of therepair device10 may be fixated to soft tissue (without thecapture member14 ofFIG.2), as depicted inFIG.11A, such that thelegs20 may be moved to the curled, formed position within thesoft tissue5 so that theanchor member12 may be anchored to the soft tissue. In this embodiment, similar to the previous embodiment, theanchor member12 may include the one or moreflexible members16 with, for example, the secondflexible member60 extending from theanchor member12 such that the secondflexible member60 may extend through thesoft tissue5 and extend from an underside of thesoft tissue5.

With reference toFIGS.4 and12, an embodiment of arepair device system150 for couplingsoft tissue5 tobone7 is provided. In this embodiment, therepair device system150 may include abone anchor152 and therepair device10 having theanchor member12 and thecapture member14, similar to that previously described. Thebone anchor152 may extend with an elongated structure defining a bone anchor axis along and axially relative to the elongated structure.Such bone anchor152 may include structure along its external surface, such as ribs or threads, to assist thebone anchor152 to couple to a pre-formed hole9 in thebone7. Thebone anchor152 may include a throughhole154 therein or other coupling feature, such as a notch or protruding extensions, sized and configured to couple the one or moreflexible members16, such as the secondflexible member60, to thebone anchor152. Upon therepair device150 being coupled tosoft tissue5 with the second flexible member extending from theanchor member12, as described and depicted inFIGS.9B,10 and11, the one or more flexible members may be threaded through, for example, thehole154 defined in thebone anchor152 to be coupled thereto. Thebone anchor152 may then be seated into and anchored in a pre-formed hole9 in thebone7 with the soft tissue cinched against the bone coupled thereto with the one or moreflexible members16. With this arrangement, therepair device10 may be employed for fixatingsoft tissue5 tobone7.

Now with reference toFIGS.4 and13, another embodiment of arepair device system160 for couplingsoft tissue5 tobone7 is provided. In this embodiment, the repair device system may include abone anchor162 and therepair device10. As previously set forth, therepair device10 may include theanchor member12 that may be coupled tosoft tissue5 with thecapture member14, similar to previous embodiments. Thebone anchor162 may include one or moreflexible members164 coupled to and extending from thebone anchor162. Such one or moreflexible members164 may be suture type filaments or the like and may be pre-coupled to thebone anchor162 or may be coupled to thebone anchor162 through the procedure of seating thebone anchor162 into thebone7. Thebone anchor162 may include anouter surface166 definingridges168 or threads to facilitate coupling to thebone7 or a base structure previously embedded in thebone7.Such bone anchor162 employed in therepair device system160 may be anysuitable bone anchor162 with one or moreflexible members164 coupled thereto. Upon embedding thebone anchor162 in thebone7 and therepair device10 being coupled to thesoft tissue5, such as tendon or ligament, the one or moreflexible members164 may be threaded through the soft tissue941 and through thecentral opening25 of theanchor member12. The one or moreflexible members164 may then be tied and knotted to the firstflexible member17 coupled to theanchor member12. Through the process of coupling the one or moreflexible members164 to the firstflexible member17, thesoft tissue5 andrepair device10 may be cinched in against or adjacent to thebone7 and/orbone anchor162 with the one or moreflexible members164. Once the one or moreflexible members164 are coupled to theanchor member12 via the firstflexible member17, any excess portions of the one or moreflexible members164 may be clipped-off by the physician.

Now with reference toFIGS.4 and14, another embodiment and method of coupling soft tissue to bone with arepair device system170 is provided. In this embodiment, similar to previous embodiments, therepair device system170 includes abone anchor172 and the repair device, therepair device10 including theanchor member12 and thecapture member14. Therepair device10 may be coupled tosoft tissue5 adjacent a soft tissue repair site and may be employed to be coupled to thebone anchor172 such that the anchor member may include the one or more flexible members, such as the firstflexible member17. Thebone anchor172 may include one or moreflexible members174 coupled thereto that extend from thebone anchor172. Upon therepair device10 being coupled to the soft tissue, the one or moreflexible members174 of thebone anchor172 may by threaded through theinner periphery54 of thecapture member14, through thesoft tissue5 and through thecentral opening25 defined in theanchor member12. The one or moreflexible members174 may then be threaded over therepair device10 and through thesoft tissue5 and through ahole176 of the bone anchor or other coupling structure of the bone anchor. The ends of the one or moreflexible members174 may then be pulled to cinch thesoft tissue5 to a desired position, such as adjacent thebone anchor172. Thebone anchor172 with thesoft tissue5 andrepair device10 cinched thereto may then be seated in a pre-formed hole in bone (not shown). In this manner, therepair device10 of this embodiment may be employed to fixatesoft tissue5 to bone.

With reference toFIGS.4 and15, another embodiment of arepair device system180 including therepair device10 that may be employed with abone anchor182 is provided. As in the previous embodiments, therepair device10 may include theanchor member12 and thecapture member14 for fixating to the soft tissue and may be employed for coupling to abone anchor182. For example, thebone anchor182 may define acentral bore184 extending within at least one end of thebone anchor182. Thebone anchor182 may also include one or moreflexible members186 extending therefrom, such as, extending from within thebore184 that may be pre-coupled to thebone anchor182. Upon seating and/or coupling thebone anchor182 intobone7 and upon deploying therepair device10 to couple to thesoft tissue5, the one or moreflexible members186 may be threaded through thecapture member14, thesoft tissue5 and through thecentral opening25 of theanchor member12. Thesoft tissue5 may then be cinched down to thebone anchor182 while the physician holds the one or moreflexible members186 taut so that thecentral opening25 of theanchor member12 and thecapture member14 are substantially aligned with thebore184 of thebone anchor182. Thesoft tissue5 may then be coupled to thebone7 andbone anchor182 by inserting apost188 through thecentral opening25 of theanchor member12 and thecapture member14 and into thebore184 of thebone anchor182. Thepost188 may define fastening structure on anouter surface185 of thepost188, such asribs187 and/or threads, sized and configured to couple to thebone anchor182 and therepair device10. As such, thepost188 may be sized and configured with tolerances to fit tight within thecentral opening25 of therepair device10 and thebore184 of thebone anchor182 such that the one or moreflexible members186 may be sandwiched between theouter surface185 of thepost188 and the corresponding inner surfaces of therepair device10 and thebone anchor182. In this manner, it may not be necessary for a physician to tie off the one or moreflexible members186 with knots since the post facilitates a coupling between the one or moreflexible members186 and therepair device10. Further, if desired, the physician may loop and thread the one or moreflexible members186 around and through therepair device10 multiple times and tie-off the one or moreflexible members186 to therepair device10 and then insert thepost188, as previously set forth, thereby providing a more fail safe dual coupling of the one or moreflexible members186 and thepost188. In either case, therepair device10 of this embodiment may be employed with thepost188 and the one or moreflexible members186 for coupling thesoft tissue5 tobone7.

With respect toFIGS.4 and16, another embodiment and method for coupling soft tissue to bone with arepair device system190 is provided. In this embodiment, therepair device system190 may include therepair device10 that may be employed with abone anchor192 and apost194. This embodiment is similar to the previous embodiment except thepost194 may be sized to only couple to therepair device10 and not directly to thebone anchor192. Similar to the previous embodiment, thepost194 may sandwich one or moreflexible members196 extending from and coupled to thebone anchor192 between an outer surface195 of thepost194 and the inner surface defining thecentral opening25 of theanchor member12 and theinner periphery54 defining a hole of thecapture member14, thereby, coupling thesoft tissue5 to thebone7. In this embodiment, the physician may not need to align thecentral opening25 of therepair device10 with thebone anchor192, but may cinch thesoft tissue5 toward thebone7 to a desired position to then simply insert thepost194 into therepair device10, which in turn, fastens the one or moreflexible members196 to therepair device10. In this manner, therepair device10 may be employed for coupling to thesoft tissue7 so that thesoft tissue5 can be coupled and fixated to thebone7 with thebone anchor192 and post194 arrangement.

Now with reference toFIGS.17A and17B, another embodiment of arepair device200 with ananchor202 and acapture member204 is provided. Theanchor202 may be sized and configured to be deployed into soft tissue to couple to thecapture member204 with the soft tissue therebetween, similar to previous repair device embodiments. Therepair device200 of this embodiment may be employed for coupling to soft tissue, such as tendon or ligament, in the shoulder or ankle regions, for example, to be coupled to bone with a bone anchor.

With respect toFIG.17A, theanchor202 may include a base206 withlegs208 extending therefrom. The base206 may exhibit a circular profile and define aninner ring portion210 and anouter ring portion212 withspokes214 extending radially between theinner ring portion210 and theouter ring portion212. Theinner ring portion210 of the anchor may define acentral opening216 of theanchor202. In addition, theouter ring portion212 may includewing portions218 extending radially outward from theouter ring portion212. Further, thelegs208 may extend downward from theouter ring portion212 between adjacently extendingwing portions218. Thewing portions218 may extend outward beyond thelegs208 to facilitate a larger area for theanchor202 to sandwich the soft tissue with thecapture member204. Thelegs208 may include structural characteristics similar tolegs208 of previous embodiments such that thelegs208 may be sized and configured to be deployed through soft tissue and configured to move to a curled position through the tissue.

With respect toFIGS.17A and17B, thecapture member204 may be sized and configured to be engaged and coupled to thelegs208 of theanchor202, thecapture member204 including a circular profile with features that correspond with theanchor202. For example, thecapture member204 may include an innercircular portion220, a middlecircular portion221, and an outercircular portion222 with spoke portions203 extending radially from the innercircular portion220 to the outercircular portion222. Thecapture member204 may also includemultiple tines224 extending from a surface of the outercircular portion222, thetines224 sized and configured to engage soft tissue. In one embodiment, thetines224 may be positioned to be aligned with and adjacent to outer ends of thespoke portions223. Further, thecapture member204 may also include acentral hole225 sized to correspond with thecentral opening216 of theanchor202. Similar to previous embodiments, thecapture member204 may be positioned on a anvil upper surface of a anvil and theanchor202 may be positioned within a cartridge. Upon positioning soft tissue over thecapture member204 and over the anvil upper surface, theanchor202 may be deployed from the cartridge such that thelegs208 of theanchor202 may extend through the soft tissue, engage anvil buckets defined in the anvil so that thelegs208 move to the curled position and wrap around a portion of thecapture member204. For example, thecapture member204 andanchor202 may be positioned such that thelegs208 curl around outer spokeportions226 of thecapture member204. With this arrangement, theanchor202 andcapture member204 may be employed for coupling soft tissue to bone similar to that depicted inFIG.11 such that one or more flexible members may be coupled to theanchor202 so that the one or more flexible members may be coupled to a bone anchor, similar to that set forth in any one of the embodiments depicted and described inFIGS.12-14.

With reference toFIGS.18A and18B, similar to the previous embodiment, another embodiment of arepair device230 having ananchor232 and acapture member234 sized and configured to couple to soft tissue, such as tendon or ligament, is provided. Theanchor232 is similar to the previous embodiment, except theanchor232 does not include the wing portions. Theanchor232 may include a base236 having aninner ring portion238 and anouter ring portion240 with radially extendingspokes242 extending therebetween, theinner ring portion238 defining acentral opening244 therein. Further, thebase236 may includelegs246 extending downward from the base236 such that thelegs246 may be positioned along the base236 in an aligned manner relative to thespokes242, thelegs246 sized and configured to move to a curled position upon deploying theanchor232 from a delivery device, similar to the previous embodiments described herein.

In this embodiment, thecapture member234 may include a base248 withspokes250, such as five spokes, extending from acentral portion252. Thecentral portion252 defines acentral hole254 configured to correspond with thecentral opening244 of theanchor232. Thespokes250 may extend radially from thecentral portion252. Further, each spoke250 may includestructure256 defining anaperture258 at an outer end thereof. Further, thestructure256 defining theaperture258 may include atine259 or spike extending therefrom sized and configured to engage and grab soft tissue. With this arrangement, thecapture member234 may be positioned on a cradle so that thelegs246 of theanchor232 may be aligned with theapertures258 of thecapture member234 such that, upon theanchor232 being deployed from the cartridge, thelegs246 extend through theapertures258 to then engage anvil buckets to curl around thestructure256 defining theapertures258. In this manner, theanchor232 and thecapture member234 may be coupled to soft tissue, similar to previous embodiments, which may be coupled to bone with one or more flexible members coupled to an embedded bone anchor, similar to that depicted inFIGS.11-14. Such one or more flexible members may be threaded through the soft tissue and thecentral opening244 of theanchor232 and thecentral hole254 of thecapture member234.

With reference toFIGS.19A and19B, another embodiment of arepair device260 having ananchor262 and acapture member264, similar to previous embodiments, is provided. Theanchor262 may include a base266 having an outercircular portion268 withspokes270 extending radially inward to acentral portion272, the base266 includinglegs274 extending downward from the outercircular portion268. Thecapture member264 may include anouter frame portion276 that may extend with a pentagon shape. Theouter frame portion276 may includestructure278 definingapertures280 along an outer periphery of theouter frame portion276, thestructure278 defining theapertures280 may be positioned adjacent corners of the pentagon shapedouter frame portion276. Theapertures280 may be sized to correspond with thelegs274 of theanchor282 such that thelegs274 may extend through theapertures280 and curl around thestructure278 defining theapertures280, similar to the previous embodiment. Further, theouter frame portion276 may includetines282 extending inward and upward from theouter frame portion276. As in previous embodiments,such tines282 of thecapture member274 may be sized and configured to engage and grab into soft tissue.

With reference toFIG.20, another embodiment of arepair device284 that may be employed for fixating to soft tissue such that therepair device284 may be coupled to bone with a bone anchor. Similar to previous embodiments, therepair device284 may include ananchor285 that may be employed alone to fixate to soft tissue and may also be employed to couple to a capture member, such as any one of the capture members described and depicted inFIGS.2,17B,18B and19B. Further, theanchor285 may be deployed from a cartridge of a delivery device, similar to that described and depicted inFIGS.8,9A and9B. Theanchor285 may include a base286 withlegs287 extending therefrom, thelegs287 sized and configured to be moved to a curled and formed position for fixating to soft tissue. The base286 may include an outer periphery and aninner periphery288, theinner periphery288 defining acentral opening289 of theanchor284. Theanchor284 of this embodiment having thecentral opening289 defined in thebase286 may be suitable to couple to a bone anchor, similar to that described and depicted relative toFIGS.11 through16. Further, theanchor285 of this embodiment may include the one or more flexible members coupled to the base286 orlegs287 of theanchor285.

With reference toFIG.21, another embodiment of ananchor292 of arepair device290 is provided. Theanchor292 of this embodiment may be employed with a corresponding capture member, similar to that set forth in previous embodiments. Theanchor292 may also be employed alone or with a capture member, similar to previous embodiments. Theanchor292 of this embodiment may include a base294 from whichlegs296 may extend, such as six legs. In another embodiment, theanchor292 may include at least fourlegs296. In another embodiment, theanchor292 may include at least fivelegs296. The base294 may include an elongated profile defining anaxis295 along the elongated profile such that thelegs296 may extend substantially perpendicular relative to theaxis295. Thelegs296, as in previous embodiments, may be sized and configured to engage anvil buckets to move to a curled position that may wrap around portions of a capture member. In this embodiment, thebase294 may include one ormore apertures298, such as two apertures, extending through thebase294.Such apertures298 may be sized and configured to extend one or more filaments therethrough for coupling theanchor292 to a bone anchor. In this manner, upon theanchor292 being coupled to soft tissue as set forth in previous embodiments, theanchor292 and soft tissue may be coupled to a bone anchor via the one or more filaments extending through the one ormore apertures298 and being coupled to theanchor292.

Now with reference toFIGS.22,23 and24, other embodiments of one or more flexible members coupled to a repair device and extending with various configurations, are provided. With respect toFIG.22, the repair device may include ananchor member300 similar to the anchor member depicted inFIG.1, such that abase302 of theanchor member300 may include a similar top view profile. In this embodiment, aflexible member304 may be coupled to the base302 such that theflexible member304 may extend between opposingrecesses306 defined in the base302 so that theflexible member304 extends in a crisscross manner to define anintersection308 betweenlength portions309 of theflexible member304. As previously set forth, a second flexible member60 (FIG.3) may then be passed over theintersection308 of theflexible member304 and extend downward from theflexible member304 and the repair device. Further, as previously set forth, the suture may be coupled to a bone anchor (not shown), similar to that set forth herein.

With respect toFIG.23, aflexible member310 may be wrapped around abase312 of ananchor member314 to exhibit a star-like configuration. In this embodiment, theanchor member314 may includemultiple recesses316 defined in thebase312, such as five recesses formed in a periphery of thebase312. With this arrangement, theflexible member310 may extend across an expanse of acentral opening318 of the base312 to crisscross at multiple locations to exhibitmultiple intersections320 ofmultiple length portions322 of theflexible member310. With this arrangement, the second flexible member (FIG.3) may be coupled to theflexible member310 to extend over one ormore length portions322 of theflexible member310 at one ormore intersections320 of theflexible member310.

With respect toFIG.24, ananchor member324 may include a base326 with twoapertures328 or recesses defined therein. In this embodiment, aflexible member330 may be wrapped through theapertures328 so that theflexible member330 extends between the twoapertures328 and over and under acentral opening332 defined in thebase member326 of theanchor member324. With this arrangement, a second flexible member60 (FIG.3) may be coupled to alength portion334 of theflexible member330 by extending over thelength portion334 of theflexible member330 and extending downward from thecentral opening332 defined in theanchor member324. In this manner, the various configurations of the flexible member (as depicted inFIGS.22,23 and24) coupled to the anchor member of the repair device may be employed as a coupling for a second flexible member60 (FIG.3) to couple to the repair device and to a bone anchor, similar to that described in other embodiments herein.

Now with reference toFIGS.25,26 and27, another embodiment of arepair device350 is provided. In this embodiment, therepair device350 may include abone anchor portion352 and a softtissue anchor portion354. Thebone anchor portion352 may be sized and configured couple tobone7. Thebone anchor portion352 may include anouter surface356 that definesribs358 or threads or the like sized and configured to couple to a base structure embedded in the bone or structure that effectively engages thebone7 itself. Further, various bone cements may also be employed and other structures and procedures for ensuring strong connection of thebone anchor portion352 in thebone7, as known to one of ordinary skill in the art.

The softtissue anchor portion354 of therepair device350 may include ananchor360 and acapture member362. Theanchor360 may includemultiple legs364 extending from aproximal side366 or surface of thebone anchor portion352.Such legs364 may be embedded within thebone anchor portion352 during, for example, a molding process of forming thebone anchor portion352. Thelegs364 may be moved from a first position to a second position, the first position being a linear elongated position (FIG.25) and the second position being a curled position (FIG.26). Thelegs364 of theanchor360 may include structural characteristics similar tolegs364 of previous embodiments set forth herein that may facilitate consistent movement of thelegs364 to the curled position, upon engaging anvil buckets of an anvil (not shown). Thecapture member362 of the softtissue anchor portion354 may include, for example, structure to facilitate thelegs364 to curl around as well as provide stability for coupling tosoft tissue5, similar to previous embodiments utilizing a capture member with an anchor. Further, similar to previous embodiments set forth herein, thecapture member362 may be positioned on an anvil with corresponding sizing relative to thecapture member362 so that thelegs364 may be pushed against anvil buckets defined in the anvil to move thelegs364 in the curled position to wrap around structure defined in thecapture member362. In this manner, thebone anchor portion352 may be coupled tobone7 and the softtissue anchor portion354 may be coupled tosoft tissue5, such as tendon or ligament, for couplingsoft tissue5 tobone7.

The various repair device embodiments or other embodiments disclosed herein may be applied to any one of various soft tissue to soft tissue repairs as well as soft tissue to bone repairs. For example, the various repair device embodiments may be employed for flexor tendon repairs, patellar tendon repairs, Achilles tendon repairs, quadriceps tendon repairs, and/or bicep tendon repairs, or any other tendon, ligament, and tendon/ligament to bone repairs, such as kidner procedures or insertional Achilles repairs, or any other tendon/ligament to bone repairs. As such, the repair device may be appropriately sized for proper fixation to the different sized or types of soft tissue.

While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. Further, the structural features of any one embodiment disclosed herein may be combined or replaced by any one of the structural features of another embodiment set forth herein. As such, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes employing any portion of one embodiment with another embodiment, all modifications, equivalents, and alternatives, falling within the spirit and scope of the invention as defined by the following appended claims.

Claims (16)

What is claimed is:

1. A repair device for fixating to soft tissue at a soft tissue repair site, comprising:

an anchor member having a base with at least four legs extending integrally from the base, the at least four legs configured to be moveable from a straight first position to a formed second position;

a capture member configured to be coupled to the anchor member such that the at least four legs of the anchor member move around structural portions of the capture member with the at least four legs of the anchor member in the formed second position; and

one or more flexible members coupled to the base of the anchor member, the one or more flexible members extending at least partially along the base of the anchor member;

wherein the one or more flexible members comprises one or more filaments sized and configured to wrap around portions of the base.

2. The repair device ofclaim 1, wherein the base comprises multiple recesses defined therein, the recesses sized and configured to receive the one or more flexible members for coupling the one or more flexible members to the base.

3. The repair device ofclaim 1, wherein the at least four legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the at least four legs, the first and second tapers of the at least four legs sized and configured to facilitate the at least four legs to be moveable to the formed second position.

4. The repair device ofclaim 1, wherein the at least four legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member.

5. The repair device ofclaim 1, wherein the one or more flexible members comprise a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member.

6. The repair device ofclaim 1, wherein the one or more flexible members are configured to be coupled to a bone anchor.

7. The repair device ofclaim 1, wherein the capture member extends with multiple apertures defined therein, each one of the multiple apertures sized and configured to correspond with one of the at least four legs of the anchor member.

8. The repair device ofclaim 1, wherein the capture member extends with a generally flat configuration.

9. A repair device system for fixating soft tissue to bone, comprising:

a bone anchor;

a soft tissue anchor member having a base with multiple legs integrally extending from the base, the legs configured to be moveable from a straight first position to a formed second position, the soft tissue anchor member configured to be coupled to soft tissue with the legs in the formed second position;

a capture member configured to be coupled to the anchor member such that the legs of the anchor member curl around structural portions of the capture member with the legs in the formed second position, the capture member including tines configured to extend upward toward the base of the anchor member; and

one or more flexible members, the soft tissue anchor being coupled to the bone anchor with the one or more flexible members.

10. The repair device system ofclaim 9, wherein the capture member extends with a generally flat configuration.

11. The repair device system ofclaim 9, wherein the multiple legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member.

12. The repair device system ofclaim 9, wherein the multiple legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the legs, the first and second tapers of the legs sized and configured to facilitate the legs to be moveable to the formed second position.

13. The repair device system ofclaim 9, wherein the one or more flexible members comprise a first flexible member and a second flexible member, the first flexible member coupled to the base of the soft tissue anchor member and the second flexible member directly coupled to the first flexible member and coupled to the bone anchor.

14. A repair device system for fixating soft tissue to bone with a bone anchor, comprising:

a delivery device having an anvil surface, the anvil surface defining anvil buckets therein;

an anchor member having a base with at least four legs extending from the base, the base including one or more flexible members coupled thereto, the at least four legs configured to be compressed against the anvil buckets to move the at least four legs to a formed configuration for fixation to the soft tissue, the one or more flexible members configured to be coupled to the bone anchor; and

a capture member configured to be positioned over the anvil surface and configured to be captured by the at least four legs of the anchor member upon the at least four legs being moved to the formed configuration, the capture member including tines configured to extend upward toward the base of the anchor member.

15. The repair device system ofclaim 14, wherein the one or more flexible members are configured to wrap around portions of the base.

16. The repair device system ofclaim 14, wherein the one or more flexible members comprise a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member.

Images